Reliability Engineer

Reliability Engineer – ADMA Biologics, Inc.

Overview

The Reliability Engineer will provide maintenance reliability, predictive maintenance, and reliability engineering support to the Manufacturing Facility. The engineer develops and maintains tools and programs that ensure equipment remains in optimal operating condition, remains cGMP compliant, and consistently meets production and quality objectives.

Key Responsibilities

• Maintain and improve the reliability and maintainability of new and modified installations, applying the Life Cycle Asset Management (LCAM) process.
• Participate in design, installation specifications, commissioning plans, and acceptance testing of new equipment.
• Develop and refine an Asset Maintenance Plan, including preventive maintenance tasks and predictive or non‑destructive testing methodologies.
• Analyze equipment performance data (Asset Utilization, Overall Equipment Effectiveness, Useful Life, etc.) and recommend solutions to improve reliability.
• Lead root‑cause investigations (RCA, RCFA, FMEA), failure reporting, and corrective action activities.
• Apply data analysis techniques such as Statistical Process Control, Reliability modeling, Fault Tree Analysis, Weibull Analysis, and Six Sigma methodology.
• Assist in design and execution of capital projects, change control, and commissioning activities.
• Provide technical support to production, maintenance management, and technical personnel, and champion best‑practice maintenance initiatives.

Qualifications

• 5+ years experience in reliability engineering/maintenance within a cGMP, pharmaceutical or biological manufacturing environment.
• Experience with process equipment such as pumps, centrifuges, refrigeration, and fluid flow systems.
• Proficiency in Microsoft Office (Word, Excel, Project) and analytical software.
• Strong communication skills, with the ability to prepare data analyses and present findings to cross‑functional teams.
• Knowledge of FDA regulations, SOPs, and quality systems.

Preferred Experience

• Experience with LCAM and asset management systems.
• Familiarity with Vendor/Contractor coordination and regulatory inspections.
• Background in troubleshooting and remediation of equipment failures and reliability issues.

Benefits

Competitive compensation, 401(k) with employer match, medical/vision/life/dental insurance, pet insurance, paid short‑term and long‑term disability, paid holidays, three weeks paid time off within the first year, tuition assistance (after the first year), free shuttle to Boca Tri‑Rail station, and E‑Verify confirmation of employment eligibility.

ADMA Biologics is an Equal Opportunity Employer.